eVerlab: Software Tool for Medical Device Safety and Performance Inspection Management

Gurbeta, Lejla; Badnjević, Almir; Kurta, Emina

doi:10.1007/978-3-030-17971-7_65

Cited by 5 publications

(6 citation statements)

References 13 publications

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“…This comes very useful because it promotes a continuous updating process, with changing claims coming from nurses, physicians, technicians, engineers or managers. This approach could be ideally complemented by vertical solutions for the inspection of medical devices such as [38,39].…”

Section: Resultsmentioning

confidence: 99%

An integrated custom decision-support computer aided facility management informative system for healthcare facilities and analysis

Iadanza

Luschi

2019

Health Technol.

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This article presents a Computer Aided Facility Management informative system which can output Key Performance Indicators and quantitative parameters about the analysed healthcare facility. The designed system is a self-sufficient application able to manage and analyse digital plans of hospital buildings with no need of third-party plugins or licenses. The system maps hospital’s inner organisation, destinations of use and environmental comforts giving quantitative, qualitative and graphical reports. The core database is linked to other existing hospital databases, so that the system can act as a central control cockpit. Outputs can be used by top-management and decisional staff as a decision-support tool in order to improve hospital’s structure and organisation and to reduce the major workflow risks. Furthermore, many plug-ins and modules have been developed through the years which can be easily linked to the main application thanks to its REST architecture, and which contribute to a complete analysis and management of the healthcare facilities.

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Section: Resultsmentioning

confidence: 99%

An integrated custom decision-support computer aided facility management informative system for healthcare facilities and analysis

Iadanza

Luschi

2019

Health Technol.

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“…Particularly, in Republic of Serbia and Bosnia and Herzegovina independent inspection bodies perform performance evaluation of 12 types of MDs: ECG devices, defibrillators, patient monitors, infant incubators, therapeutic ultrasounds, dialysis machines, anesthesia machines, mechanical ventilators, infusomats, perfusion pumps, high-frequency surgical units and blood pressure devices [59][60][61][62][63]. The results of these inspections are reported in medical device registry [49][50][51] and are used for MD surveillance. Similarly to the intentions of regulators in Japan, the MD performance evaluation data in this registry is considered as a way to enable effective track of MD performance providing prompt response to potential problems as it is shift to evidence-based surveillance of a specific device without generalization to model or manufacturer taking into account the environment in which MD is used.…”

Section: Discussionmentioning

confidence: 99%

“…With respect to the EUDAMED or MAUDE database this standardization means that surveillance of MDs can be performed on performance and safety parameters which opens new possibilities toward application of artificial intelligence in this field. As mentioned above, the countries which adopted PMS as part of the legal metrology framework already have national medical device registries with safety and performance measurements [49] which enables data management and introduction of novel tools for data analysis and even performance prediction [75][76][77][78][79][80][81]. However, these medical device registries are not as wide as EUDAMED or MAUDE databases for instance.…”

Section: Discussionmentioning

confidence: 99%

“…This registration is a prerequisite for placement of MD on the national market, and the placement itself is prerequisite for all other PMS strategies which follow MD on the market. In some countries, who adopted different schemes of PMS, as will be shown in part c), different medical device registries exist [49][50][51]. Gurbeta et al [50] explain how an independent inspection body performing PMS developed digital medical device registries for MD safety and performance inspection management.…”

Section: Medical Device Registrymentioning

confidence: 99%

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Post-market surveillance of medical devices: A review

Badnjević

Pokvić

Deumić

et al. 2022

THC

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BACKGROUND: Medical devices (MDs) represent the backbone of the modern healthcare system. Considering their importance in daily medical practice, the process of manufacturing, marketing and usage has to be regulated at all levels. Harmonized evidence-based conformity assessment of MDs during PMS relying on traceability of medical device measurements can contribute to higher reliability of MD performance and consequently to higher reliability of diagnosis and treatments. OBJECTIVE: This paper discusses issues within MD post-market surveillance (PMS) mechanisms in order to set a path to harmonization of MD PMS. METHODS: Medline (1980–2021), EBSCO (1991–2021), and PubMed (1980–2021) as well as national and international legislation and standard databases along with reference lists of eligible articles and guidelines of relevant regulatory authorities such as European Commission, Food and Drug Administration were searched for relevant information. Journal articles that contain information regarding PMS methodologies concerning stand-alone medical devices. National and international legislation, standards and guidelines concerning the topic. RESULTS: The search strategy resulted in 2282 papers. Out of those only 24 articles satisfied the eligibility criteria and were finally included in the review. Papers were grouped per categories: medical device registry, medical device adverse event reporting, and medical device performance evaluation. In addition to journal articles, national and international legislation, standards, and guidelines were reviewed to assess the state of PMS in different regions of the world. CONCLUSION: Although the regulatory framework prescribes PMS of medical devices, the process itself is not harmonized with international standards. Particularly, conformity assessment of MDs, as an important part of PMS, is not measured and managed in a traceable, evidence-based manner. The lack of harmonization within PMS results in an environment of increased adverse events involving MDs and overall mistrust in medical device diagnosis and treatment results.

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“…Conformity assessment is performed to verify the safety and the declared performance as stated by the manufacturer. [26][27][28] Depending on the type of device, it is the manufacturers' legal obligation to obtain a certificate from a Notifying Body (entity chosen by individual Member States and listed on the URPL's website). The certificate is obtained for a series of devices and not individual equipment.…”

Section: Discussionmentioning

confidence: 99%

Safety of Medical Devices in Poland – Analysis of Withdrawn and Suspended Certificates of Compliance

Patryn

Zagaja

Drozd

2021

MDER

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Introduction: In the European Union, the process of controlling currently used medical devices is carried out and determined by legal provisions. The law stipulates that each entity responsible for using medical equipment must confirm its safety with an appropriate certificate issued by a notifying body. In Poland, the entity responsible for keeping records as to the withdrawn and suspended certificates, is the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products (URPL). Certification is required for all medical devices prior to their introduction onto the market and during their use. Purpose: The article presents data concerning the number of medical devices that failed to meet the certification criteria. Methods: The research method is an analysis of available subject literature and a report on withdrawn and suspended certificates of medical devices in Poland. Results: In the years 2014-2020, the notified bodies withdrew and suspended 13,354 certificates for medical devices, of which 9792 certificates were withdrawn, 2852 suspended and one falsified. Conclusion:The suspension or withdrawal of a certificate for medical devices due to the inefficiency, obsolescence, imprecision, or safety of the devices is an action that improves the safety of patients. Such action reduces the number of medical damages and the obligation to pay compensation to those injured.

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eVerlab: Software Tool for Medical Device Safety and Performance Inspection Management

Cited by 5 publications

References 13 publications

An integrated custom decision-support computer aided facility management informative system for healthcare facilities and analysis

An integrated custom decision-support computer aided facility management informative system for healthcare facilities and analysis

Post-market surveillance of medical devices: A review

Safety of Medical Devices in Poland – Analysis of Withdrawn and Suspended Certificates of Compliance

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